Biologically implantable prosthesis and methods of using the same

ABSTRACT

A heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a plurality of magnets on the first and second prostheses to secure the second prosthesis to the first prosthesis. In one embodiment, the magnets are arranged to allow the second prosthesis to be secured to the first prosthesis in a predetermined angular orientation. During use, the first annular prosthesis is implanted into the annulus, and the second valve prosthesis is inserted into the annulus. The magnets orient the second prosthesis relative to the first prosthesis to align the second prosthesis with the first prosthesis in a predetermined angular orientation; and secure the second prosthesis to the first prosthesis in the predetermined angular orientation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/080,009, filed Mar. 14, 2005, entitled “Biologically ImplantableProsthesis And Methods Of Using The Same”, which is a continuation ofco-pending application Ser. No. 10/327,821, filed Dec. 20, 2002, theentire teachings of which are incorporated herein by reference.

BACKGROUND

1. Field of the Invention

The present invention relates generally to a biologically implantableprosthesis, a heart valve assembly using the prosthesis, and methods ofusing the same within an annulus of the body.

2. Description of the Related Art

Prosthetic heart valves can replace defective human valves in patients.Prosthetic valves commonly include sewing rings or suture cuffs that areattached to and extend around the outer circumference of the prostheticvalve orifice.

In a typical prosthetic valve implantation procedure, the heart isincised and the defective valve is removed leaving a surrounding area oflocally tougher tissue. Known heart valve replacement techniques includeindividually passing sutures through the tough tissue to form an arrayof sutures. Free ends of the sutures are extended out of the thoraciccavity and laid, spaced apart, on the patient's body. The free ends ofthe sutures are then individually threaded through an edge around thecircumference of the sewing ring. Once all sutures have been run throughthe ring, all the sutures are pulled up taught and the prosthetic valveis slid or “parachuted” down into place adjacent the tough tissue.Thereafter, the prosthetic valve is secured in place by traditional knottying with the sutures.

The sewing ring is often made of a biocompatible fabric through which aneedle and suture can pass. The prosthetic valves are typically suturedto a biological mass or annulus that is left when the surgeon removesthe existing valve from the patient's heart. The sutures are tiedsnugly, thereby securing the sewing ring to the annulus and, in turn,the prosthetic valve to the heart.

Sewing rings can be tedious to secure to the valve orifice. Further,attaching the sewing ring to the annulus can be time consuming andcumbersome. The complexity of suturing provides a greater opportunityfor mistakes and requires a patient to be on cardiopulmonary bypass fora lengthy period. It is also desirable to provide as large of a lumenthrough the prosthetic valve as possible to improve hemodynamics.However, techniques for attaching the sewing ring to the orificetypically require the area of the valve lumen be reduced to accommodatean attachment mechanism. For example, the sewing ring is typicallyretained on top of the annulus, resulting in a lumen that is, at thelargest, the size of the original lumen.

A patient can also have a natural valve lumen that is detrimentallysmall. In these cases, the natural valve can be gusseted before theprosthetic valve is implanted. To gusset the natural valve, alongitudinal incision can be made along the wall of the lumen. The lumencan then be circumferentially expanded and the now-expanded incision canbe covered with a patch graft or other membrane and stitched closed.

U.S. Pat. No. 4,743,253 to Magladry discloses a suture ring with acontinuous compression ring. Magladry's ring is ductile, but provides acompressive, not expansive, force. In fact, the ring taught by Magladryis intended for placement over a heart valve and provides compression onthe heart valve.

U.S. Pat. No. 6,217,610 to Carpentier et al. discloses an expandableannuloplasty ring. Carpentier et al. teach expanding the ring over thelife of a patient by increasing the size of the ring by balloondilatation. The ring is intended to remodel the shape of the valveannulus, not serve as a foundation to attach a second prosthesis andform a heart valve.

U.S. Pat. No. 5,984,959 to Robertson et al. discloses an expandableheart valve ring for attaching a synthetic valve thereto and a tool forattaching the ring to the synthetic valve. Robertson et al. teach thering as having tabs that are used to attach to the second prosthesis byusing a second device to engage the tabs.

There is a need for a circumferentially expandable bio-prosthesis. Thereis also a need for a prosthesis and method that can expand an annulusand maintain an enlarged annulus circumference. Furthermore, there is aneed for a minimally invasive heart valve replacement procedure. Also,there is a need for a prosthesis that can provide for the above andengagement with a second prosthesis, for example, the crown of a heartvalve. Furthermore, there is a need for the above prosthesis that canself-engage a second prosthesis to improve implantation time.

SUMMARY

One embodiment of the disclosed prosthesis is a biologically implantablefirst prosthesis for a heart valve having a circumferentially expandablewall. The wall has a latitudinal cross-section perpendicular to thelongitudinal axis, and a longitudinal cross-section parallel to thelongitudinal axis. The prosthesis also has an engagement elementconfigured to self-engage a second prosthesis.

The first prosthesis can also have a stop, where the stop prevents thewall from circumferentially decreasing. The first prosthesis can alsohave a fixturing device connector. The wall can also be corrugated. Thewall can also have a turned lip on its leading edge. The firstprosthesis can also be in an assembly where the first prosthesis canreceive a second prosthesis, for example a crown.

Another embodiment of the prosthesis is a biologically implantable firstprosthesis for a heart valve having a wall with a first edge and asecond edge. The wall has a longitudinal axis at the center of the firstprosthesis, and the first edge has an engagement element for engaging asecond prosthesis. The engagement element is also turned toward thesecond edge.

The engagement element can be curved toward the second edge. The firstedge can be the leading edge. The first prosthesis can also have afixturing device connector that can be a port in the wall. The wall canalso be corrugated. The first prosthesis can also be in an assembly witha second prosthesis connected to the engagement element. The secondprosthesis can be a crown.

An embodiment of a method of implanting a heart valve in a valve annulusis attaching a first prosthesis to the valve annulus and attaching asecond prosthesis to the first prosthesis. The first prosthesis has acircumferentially expandable wall. The wall has a longitudinal axis, andthe wall has a latitudinal cross-section perpendicular to thelongitudinal axis.

The first prosthesis can be a ring. The second prosthesis can be acrown. The wall of the first prosthesis can have a first terminal endand a second terminal end. Attaching the first prosthesis can includefixing the first prosthesis to a biological mass with a fixturingdevice. Attaching the first prosthesis can also include snap-fitting thesecond prosthesis to the first prosthesis.

Another embodiment of a method of implanting a heart valve in a valveannulus includes attaching a first prosthesis to the valve annulus andattaching a second prosthesis to the first prosthesis. The firstprosthesis has a wall having a first edge and a second edge. The wallalso has a longitudinal axis. The first edge comprises an engagementelement, and the engagement element is turned toward the second edge.

The engagement element can be turned away from the longitudinal axis.The first prosthesis can be a ring. The second prosthesis can be acrown. Attaching the crown can include snap-fitting the crown to thefirst prosthesis.

An embodiment of a method of increasing and maintaining the size of abiological valve annulus includes placing a circumferentially expandablefirst prosthesis in the annulus. The method also includescircumferentially expanding the first prosthesis, and circumferentiallylocking the first prosthesis.

Circumferentially expanding the first prosthesis can include increasingthe radius of the annulus from about 0.1 mm (0.004 in.) to more thanabout 2.0 mm (0.08 in.). The first prosthesis can also have anengagement element configured to receive a second prosthesis.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a bottom view of an embodiment of the prosthesis.

FIG. 2 is a top perspective view of the embodiment of the prosthesis ofFIG. 1.

FIG. 3 is a bottom view of another embodiment of the prosthesis.

FIG. 4 is a top perspective view of the embodiment of the prosthesis ofFIG. 3.

FIG. 5 is a bottom view of another embodiment of the prosthesis.

FIG. 6 is a top perspective view of the embodiment of the prosthesis ofFIG. 5.

FIG. 7 is a bottom view of another embodiment of the prosthesis withcut-away views of the collars.

FIG. 8 is a top perspective view of the embodiment of the prosthesis ofFIG. 7 with cut-away views of the collars.

FIG. 9 is a bottom view of another embodiment of the prosthesis withcut-away views of the collars.

FIG. 10 is a top perspective view of the embodiment of the prosthesis ofFIG. 8 with cut-away views of the collars.

FIG. 11 is a top perspective view of another embodiment of theprosthesis with magnets.

FIG. 12 illustrates cross-section A-A of FIG. 11.

FIG. 13 is a top perspective view of another embodiment of theprosthesis with magnets.

FIG. 14 illustrates cross-section B-B of FIG. 13.

FIG. 15 is a top perspective view of another embodiment of theprosthesis with magnets.

FIGS. 16-18 are top views of various deformable embodiments of theprosthesis in unexpanded states.

FIG. 19 is a top view of the embodiment of the prosthesis of FIG. 12 inan expanded state.

FIGS. 20-22 illustrate various embodiments of the fixturing deviceconnectors.

FIGS. 23-25 illustrate various embodiments of the receiving elements.

FIGS. 26 and 27 are cut-away views of various embodiments of thereceiving elements.

FIGS. 28-33 illustrate various embodiments of the protrusions.

FIG. 34 illustrates the steering elements.

FIGS. 35-43 are cross-sections of various embodiments of the wall of theprosthesis.

FIG. 44 illustrates an embodiment of the prosthesis of FIG. 38.

FIGS. 45 and 46 illustrate cross-sections of the wall of the prosthesiswith various embodiments of the covering.

FIGS. 47-52 illustrate various embodiments of the engagement element.

FIG. 53 is a cut-away view of an embodiment of positioning theprosthesis in an annulus with a solid view of the prosthesis.

FIG. 54 is a cut-away view of an embodiment of positioning theprosthesis in an annulus.

FIGS. 55 and 56 illustrate various embodiments of the protrusions andreceiving elements when the prosthesis is not expanded.

FIG. 57 is a cut-away view of an embodiment of expanding the prosthesis.

FIGS. 58 and 59 illustrate an embodiment of an expansion tool.

FIGS. 60 and 61 illustrate another embodiment of an expansion tool.

FIGS. 62 and 63 illustrate various embodiments of the protrusions andreceiving elements when the prosthesis is expanded.

FIG. 64 is a cut-away view of fixturing the prosthesis to a biologicalmass.

FIGS. 65-68 illustrate an embodiment of a method and assembly forfixturing the prosthesis to a biological mass.

FIG. 69 is a cut-away view of positioning the second prosthesis onto thefirst prosthesis with a solid view of the second prosthesis.

FIG. 70 is a cut-away view of attaching the second prosthesis to thefirst prosthesis.

FIGS. 71-77 are exploded views of various embodiments of attaching thesecond prosthesis to the first prosthesis.

FIG. 78 is an exploded view of an embodiment of attaching the secondprosthesis to an adapter and attaching the adapter to the firstprosthesis.

FIGS. 79 and 80 illustrate cross-sections C-C and D-D, respectively,from FIG. 78.

FIG. 81 is a top view of an embodiment of the first prosthesis with thesecond prosthesis attached thereto.

FIGS. 82-84 illustrate an embodiment of a method of removing the secondprosthesis from the first prosthesis.

DETAILED DESCRIPTION

FIGS. 1 and 2 illustrate an embodiment of a biologically implantablefirst prosthesis 2. The first prosthesis 2 can have a wall 4. The wall 4can have material strength and dimensions known to one having ordinaryskill in the art to make the first prosthesis resiliently expandable.The wall 4 can have an open form or spiral longitudinal cross-section,as shown in FIG. 1. The longitudinal cross-section can be perpendicularto a central longitudinal axis 6.

The wall 4 can have a first terminal end 8 and a second terminal end 10.Each end 8 and 10 can be defined from a midpoint 12 of the wall 4 to afirst terminus 14 or a second terminus 16 of the wall 4 at therespective end 8 or 10. The wall 4 can have an end difference length 18.The end difference length 18 can be the shortest angular length from thefirst terminus 14 to the second terminus 16. The wall 4 can also have aleading edge 20 and a trailing edge 22. The leading edge 20 and trailingedge 22 can be substantially perpendicular to the longitudinal axis 6.The first prosthesis 2 can have a circumference equivalent to a walllength 24 minus an end difference length 18. The wall 4 can have a wallheight 25. The wall height can be from about 3.18 mm (0.125 in.) toabout 12.7 mm (0.500 in.), for example about 8.26 mm (0.325 in.). Thewall 4 can also be void of any attachment device with which to fix oneend 8 or 10 of the wall 4 to the other end 8 or 10 of the wall 4. Thewall 4 can made from stainless steel alloys, nickel titanium alloys(e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from ElginSpecialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp.,Wyomissing, Pa.), polymers such as polyester (e.g., DACRON® from E. I.Du Pont de Nemours and Company, Wilmington, Del.), polypropylene,polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether etherketone (PEEK), nylon, extruded collagen, silicone, radiopaque materialsor combinations thereof. Examples of radiopaque materials are barium,sulfate, titanium, stainless steel, nickel-titanium alloys and gold.

FIGS. 3 and 4 illustrate an embodiment of the first prosthesis 2 thatcan be mechanically expandable. A first protrusion 26 and a secondprotrusion 28 at the first terminal end 8 can extend from the wall 4.The protrusions 26 and 28 can extend perpendicular to the wall 4 orperpendicular to the longitudinal axis 6. The protrusions 26 and 28 canbe tabs, brads, extensions, balls, rods or a combination thereof. Theprotrusions can have a protrusion depth 30 sufficient to retain the wall4.

The wall 4 can also have a first receiving element 32 and a secondreceiving element 34 at the second terminal end 10 that receive orengage the first protrusion 26 and the second protrusion 28,respectively. The wall 4 can also have more or less (e.g., one or zero)receiving elements 32 or 34. The receiving elements 32 and 34 can beholes in the wall 4. The receiving elements 32 and 34 can also bedivets, dimples, hooks, slots, or a combination thereof. The protrusions26 and 28 and receiving elements 32 and 34 can act together as a stop,or an interference fit, to prevent the first prosthesis 2 fromcircumferentially extending or decreasing beyond desired limits.

FIGS. 5 and 6 illustrate an embodiment of the first prosthesis 2 thatcan have protrusions 26 and receiving elements 32 that can be dimples.The protrusions 26 and receiving elements 32 can be in a first row 36, asecond row 38, and additional rows 40. The protrusions 26 can also be ina first column 42, a second column 44, and additional columns 46. Thereceiving elements 32 can have a receiving element depth 46 within thesame range of sizes as the protrusion depth 36, above.

FIGS. 7 and 8 illustrate an embodiment of the first prosthesis 2 thatcan have the protrusions 26 and 28 extending from the first terminus 14substantially at a tangent to the wall 4. The protrusions 26 and 28 canbe rods 48 with balls 50 at the ends of the rods 48. The receivingelements 32 and 34 can extend from the second terminus 16 substantiallyat a tangent to the wall 4. The receiving elements 32 and 34 can becollars 52 for receiving the balls 50. The wall 4 can have alongitudinal cross-section in the shape of a circular open curve, asshown in FIG. 7. A circumferential gap 54 can exist between the firstterminus 14 and the second terminus 16.

FIGS. 9 and 10 illustrate an embodiment of the first prosthesis 2 thatcan have different embodiments of protrusions 26 and 28 and receivingelements 32 and 34. The first prosthesis 2 of FIGS. 9 and 10 can alsohave a wall angle 56 relative to the longitudinal axis 6 controlled bythe dimensions of the protrusions 26 and 28 and receiving elements 32and 34 and the locations of the protrusions 26 and 28 and receivingelements 32 and 34 on the wall 4. The wall angle 56 can be from about10° to about 60°, more narrowly from about 20° to about 45°, for exampleabout 25°. The protrusions 26 and 28 and the receiving elements 32 and34 can be located along the trailing edge 22, the leading edge 20 ortherebetween.

FIGS. 11 and 12 illustrate an embodiment of the first prosthesis 2 withthe wall 4 having a bottom segment 58 and a top segment 60. The firstprosthesis 2 can be deformably circumferentially expandable. The bottomsegment 58 can have the wall angle 56 relative to the longitudinal axis6. The angle between the bottom segment 58 and the top segment 60 can bea joint angle 62. The joint angle 62 can be from about 90° to about180°, more narrowly from about 90° to about 160°, for example about120°. The wall 4 can also have a first steering groove 64 that canextend over the length of the bottom segment 58. The wall 4 can alsohave a second steering groove 66 that can extend over a portion of thelength of the bottom segment 58. The grooves 64 and 66 can helpangularly align, with respect to the longitudinal axis 6, a secondprosthesis 68 that can be attached to the first prosthesis 2. Thegrooves 64 and 66 can also prevent the rotation of the first prosthesis2 with respect to the second prosthesis 68. The second groove 66 canalso help to longitudinally align the second prosthesis 68.

The first prosthesis 2 can also have engagement elements, for exampletop magnets 70 in the top segment 60 and bottom magnets 72 in the bottomsegment 58. The magnets 70 and 72 can have a magnet height 74, a magnetwidth 76 and a magnet length 78. The magnets 70 and 72 can be rareearth, high strength-type magnets. The magnets can be made fromneodymium-iron-boron and can be encapsulated in a coating made from PTFE(e.g., TEFLON® (from E. I. Du Pont de Nemours and Company, Wilmington,Del.), PEEK, a similarly inert and stable biocompatible polymer, or acombination thereof. A radiopaque material can also be added to thecoating. The top and/or bottom magnets 70 and/or 72 can be customized toallow for only one angular orientation of the second prosthesis 68 bychanging the polarity of one or an irregular number of magnets 70 and/or72 (e.g., positive) to be different from the polarity of the remainingmagnets 70 and/or 72 (e.g., negative).

In one example, 24 magnets 70 can be evenly distributed around thecircumference of the first prosthesis 2. The magnet heights 74 can beabout 3.175 mm (0.125 in.). The magnet widths 76 can be about 3.175 mm(0.125 in.). The magnet lengths 78 can be about 1.59 mm (0.0625 in.).

FIGS. 13 and 14 illustrate an embodiment of the first prosthesis 2similar to the embodiment illustrated in FIGS. 11 and 12. The presentembodiment of the first prosthesis 2 can have a cloth sewing surface 80.The magnets 70 can be square or rectangular in cross-section (as shownin FIGS. 11 and 12) or oval or circular in cross-section (as shown inFIGS. 13 and 14). The wall 4 can also be multiple segments 58 and 60, asshown in FIGS. 11 and 12, or a single segment, as shown in FIGS. 13 and14.

FIG. 15 illustrates an embodiment of the first prosthesis 2 similar tothe embodiment illustrates in FIGS. 11 and 12. The first prosthesis 2 inthe present embodiment can also be mechanically and/or resilientlycircumferentially expandable.

FIGS. 16-18 illustrate deformable embodiments of the first prosthesis 2.In an unexpanded state, the first prosthesis 2 can have an unexpandeddiameter 82. The embodiment of the first prosthesis 2 in FIG. 16 canhave a smooth wall 4, thereby relying on hoop strain to expand. In FIG.17, the embodiment can have an accordianed wall 4 with multiple pleatsor folds 84. The folds 84 can open or unfold to maximize circumferentialexpansion of the wall 4 during use. The embodiment of the firstprosthesis 2 in FIG. 18 can have a single large fold 84 for the samepurpose as the folds 84 shown in FIG. 17. FIG. 19 illustrates adeformable embodiment of the first prosthesis 2 in an expanded state. Aradial force, as shown by arrows, directed away from the longitudinalaxis 6 can expand the first prosthesis 2 to an expanded diameter 86.Materials and dimensions of the first prosthesis 2 can be selected byone having ordinary skill in the art to permit the ratio of theunexpanded diameter 82 to the expanded diameter 86 to be from about 0%to about 50%, more narrowly from about 5% to about 20%, yet morenarrowly from about 9% to about 12%, for example about 9.5%.

FIG. 20 illustrates a length of the wall 4 that can have a firstfixturing device connector 88 and a second fixturing device connector90. The fixturing device connectors 88 and 90 can be ports or holes inthe wall 4. The fixturing device connectors 88 and 90 can be ovular andcan have a fixturing device connector height 92 and a fixturing deviceconnector length 94. The fixturing device connector height 92 can befrom about 0.51 mm (0.020 in.) to about 3.18 mm (0.125 in.), morenarrowly from about 1.0 mm (0.040 in.) to about 1.5 mm (0.060 in.), forexample about 1.3 mm (0.050 in).

FIG. 21 illustrates a length of the wall 4 that can have first, second,and additional fixturing device connectors 88, 90 and 96. The fixturingdevice connectors 88, 90 and 96 can be circular in shape. FIG. 22illustrates a length of the wall 4 that can have the fixturing deviceconnectors 88, 90 and 96 attached to the leading and trailing edges 20and 22. The fixturing device connectors 88, 90 and 96 can be made fromfabric or metal, for example polymers such as polyester (e.g., DACRON®from E. I. Du Pont de Nemours and Company, Wilmington, Del.),polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone,stainless steel alloys, nickel-titanium alloys (e.g., Nitinol),cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin,Ill., CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.) orcombinations thereof. Variously shaped and configured fixturing deviceconnectors 88, 90 and 96 can be on the same wall 4.

FIG. 23 illustrates a length of the wall 4 that can have the receivingelements 32 and 34. The receiving elements 32 and 34 can be ports orholes in the wall 4. The receiving elements 32 and 34 and the fixturingdevice connectors 88, 90 and 96 can be the same element. The receivingelements 32 and 34 can have a first setting position 98 and a first neck100 at one end of the first setting position 98. The first settingposition 98 can have a setting position length 102 from about 4 mm (0.2in.) to about 10 mm (0.4 in.), for example about 6.3 mm (0.25 in.). Thefirst neck 100 can have a neck width 104. The first neck 100 can be at afirst end of a second setting position 106. The receiving elements 32and 34 can have more or less than two setting positions 98 and 106(e.g., one or zero). At a second end of the second setting position 106,the second setting position 106 can have a second neck 108. The secondneck 108 can be at a first end of a final stop position 110. The finalstop position 110 can have a final stop length 112.

The first and second setting positions 98 and 106 can lead to the firstand second necks 100 and 108, respectively, with a ramp angle 114. Thestop position 110 and the second setting position 106 can lead to thesecond 108 and first necks 100, respectively, with a stop angle 116.

FIG. 24 illustrates narrowing oval or teardrop-shaped receiving elements32 and 34. FIG. 25 illustrates rectangular receiving elements 32 and 34.

FIG. 26 illustrates the receiving element 32 that can be in the shape ofa collar or sleeve. The receiving element 32 can be attached by aconnection zone 118 to a rod (not shown) extending from the wall 4 or tothe wall 4 itself. The receiving element 32 can have first wedges 120and second wedges 122. The length between the closest point of the firstwedges 120 or of the second wedges 122 can be the neck width 104. Thewedges 120 and 122 can revolve around the entire receiving element 32,thereby forming a single, circular first wedge 120 and a single,circular second wedge 122 (when seen in three-dimensions).

A receiving element shaftway 124 can be open at one end of the receivingelement 32. The receiving element 32 can have a first narrowing 126 nearthe connection zone 118 and a second narrowing 128 near the receivingelement shaftway 124. FIG. 27 illustrates the receiving element 32 thatcan have the wedges 120 and 122 shaped as scales or stop tabs.

A length of the wall 4 that can have protrusions 26 and 28 isillustrated in FIG. 28. The protrusions 26 and 28, shown alone invarious embodiments in FIGS. 29 and 25, can be made from an extension130 and a cuff 132. The extension 130 can be shaped cylindrically or, asshown in FIG. 30, as a shaft with a triangular cross-section. Theextension 130 can have an extension height 134 and an extension width136. The extension height 134 can be from about 0.51 mm (0.020 in.) toabout 2.54 mm (0.100 in.), for example about 1.3 mm (0.050 in.). Thefinal stop length 112 can be from about the extension width 136 to about10 mm (0.4 in.), for example about 6.3 mm (0.25 in.).

The cuff 132 can be shaped as a circle or a square and can besubstantially flat in depth. The cuff 132 can have a cuff height 138 anda cuff width 140. The cuff height 138 can be from about the fixturingdevice connector height 92 to about 5.08 mm (0.200 in.), for exampleabout 2.0 mm (0.080 in). The cuff width 140 can be within the range forthe cuff height 138, above.

FIG. 31 illustrates a length of the wall 4 having the protrusions 26 and28 formed from tabs cut out of the wall 4. Cut holes 142 can exist inthe wall 4 where the material in the protrusions 26 and 28 was locatedin the wall 4 before being cut out.

FIG. 32 illustrates a length of the wall 4 that can have a first set anda second set of protrusions 26 and 28 extending from the wall 4. Thewall 4 can have a wall radius of curvature 144. The protrusions 26 and28 can have protrusion radii of curvature 146. The protrusion radii ofcurvature 146 can be from about the wall radius of curvature 144 toinfinity.

FIG. 33 illustrates a length of the wall 4 that can have an engagementelement 148. The engagement element 148 can be shaped as a lip andwrapped around the protrusion 26. The engagement element 148 can enablethe first prosthesis 2 to self-engage the second prosthesis 68. Forexample, the engagement element 148 can snap-fit to the secondprosthesis 68.

FIG. 34 illustrates the first terminal end 8 and the second terminal end10. The second terminal end 10 can have a first guide 150 and a secondguide 152 that can wrap around the leading edge 20 and the trailing edge22, respectively, of the first terminal end 8. The first terminal end 8can slide angularly, with respect to the longitudinal axis 6, within theguides 150 and 152. The guides 150 and 152 can also minimize the risk ofthe first terminal end 8 moving too far away from or becoming misalignedfrom the second terminal end 10.

FIGS. 35-43 illustrate embodiments of the first prosthesis 2 at alatitudinal cross-section. The latitudinal cross-section can be across-section parallel with the longitudinal axis 6. FIG. 35 illustratesan embodiment with the wall 4 having a corrugated latitudinalcross-section. FIG. 36 illustrates an embodiment with the wall 4 havinga straight latitudinal cross-section, parallel with the longitudinalaxis 6.

FIG. 37 illustrates an embodiment having the trailing edge 22 angledtoward the longitudinal axis 6 at the wall angle 56. FIG. 38 illustratesan embodiment having the trailing edge 22 angled away from thelongitudinal axis 6 at the wall angle 56.

FIG. 39 illustrates an embodiment having a wall 4 convex toward thelongitudinal axis 6. The wall 4 can be straight or have a lateral convexradius of curvature 154. FIG. 40 illustrates an embodiment having a wall4 concave toward the longitudinal axis 6. The wall 4 can have a lateralconcave radius of curvature 156 within the same range as the lateralconvex radius of curvature 154.

FIG. 41 illustrates an embodiment having a wall 4 with a top segment 60,a middle segment 158 and a bottom segment 58. The top segment 60 andleading edge 20 can be angled away from the longitudinal axis 6. Thebottom segment 58 and trailing edge 22 can be angled away from thelongitudinal axis 6. The middle segment 158 can remain parallel to thelongitudinal axis 6.

FIG. 42 illustrates an embodiment having the top segment 60 and theleading edge 20 that can be angled toward the longitudinal axis 6. Thebottom segment 58 and trailing edge 22 can also be angled toward thelongitudinal axis 6. The middle segment 158 can remain parallel to thelongitudinal axis 6.

FIGS. 43 and 44 illustrate an embodiment of the wall 4 that can have abottom segment 58 that can extend from the wall 4 at a retainer angle160 with respect to the longitudinal axis 6 from about 0° to about 90°,more narrowly from about 10° to about 50°, for example about 30°. Thebottom segment 58 can also have cuts 162, shown in FIG. 44. The cuts 162can minimize stresses when the bottom segment 58 fans away from themiddle segment 158. The bottom segment 58 can also act as a retentionelement, extending beyond the typical trailing edge 22 and stabilizingthe first prosthesis 2 after the first prosthesis 2 is implanted.

FIG. 45 illustrates a cross-section of the wall 4 that can have a fabriccovering 164, for example polyester (e.g., DACRON® from E. I. du Pont deNemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE,nylon, extruded collagen, silicone or combinations thereof. The fabriccan be attached to the wall 4 at a first attachment point 166 and asecond attachment point 168. The bare area of the wall between theattachment points 166 and 168 can be the engagement surface 170. Thesecond prosthesis 68 can engage the first prosthesis 2 at the engagementsurface 170.

FIG. 46 illustrates a cross-section of the wall 4 covered entirely bythe covering 164. The second prosthesis 68 can also engage the firstprosthesis 2 at the engagement surface 170 covered by the covering 164.

FIG. 47 illustrates a length of wall 4 with the engagement element 148,shaped as an open lip, on the leading edge 20. The engagement element148 can be turned toward the longitudinal axis 6 and toward the trailingedge 22. FIG. 48 illustrates the engagement element 148 turned away fromthe longitudinal axis 6 and toward the trailing edge 22.

FIGS. 49 and 50 illustrate an embodiment of the first prosthesis 2 thatcan have a first length 172, a second length 174 and a third length 176.The lengths 172, 174 and 176 can be separated by cuts 162 in the wall 4.The engagement element 148 on the first length 172 and third length 176can turn toward the longitudinal axis 6. The top and middle segments 60and 158 of the first length 172 and the third length 176 can be bentaway from the bottom segment 58 as shown by the arrows in FIG. 50. Thetop and middle segments 60 and 158 of the second length 174 can besimilarly bent but in the opposite direction to the top and middlesegments 60 and 158 of the first and third lengths 172 and 176. Theengagement element 148 on the second length 174 can turn away from thelongitudinal axis 6. A lip length 178 can be the length between a firstlip edge 180 of the engagement element 148 on the first length 172 orthird length 176 and a second lip edge 182 of the engagement element 148on the second length 174. The lip length 178 can be small enough to forma seam, crease or seat 184 to aid in seating, receiving and engaging asecond prosthesis.

FIG. 51 illustrates a length of the wall 4 that can have the lengths172, 174 and 176. The engagement elements 148 on the first length 172and third length 176 can turn away from the longitudinal axis 6. Theengagement element 148 on the second length 174 can turn toward thelongitudinal axis 6. The engagement element 148 can then engage a secondprosthesis on both sides of the wall 4.

FIG. 52 illustrates an embodiment that can have springs 186. One segmentof each spring 186 can be a latch 188. The springs 186 can have windings190 around a rail 192 fixed under the engagement element 148. Thesprings 186 can also have retaining legs 194 pressed against the wall 4.The latches 188 can be biased to contract, as shown by arrows 196,against the wall 4. The latches 188 can be held in the uncontractedposition shown in FIG. 52 by interference beams 198. The interferencebeams 198 can be directly or indirectly rigidly attached to each otherat a proximal end (in the direction of arrows 200) to minimize theinterference beams 198 from deflecting under the force, shown by arrows196, from the latches 188. The interference beams 198 can be removed, asshown by arrows 200, allowing the latches 188 to contract, as shown byarrows 196, against, for example, the second prosthesis, once the secondprosthesis is positioned within the reach of the latches 188.

Method of Making

The wall 4 can be made from methods known to one having ordinary skillin the art. For example, the wall 4 can be molded or machined. Theengagement element 148, the corrugation and any other bends in the wall4 can be formed (e.g., pressure formed), molded or machined into thewall 4 or bent into the metal with methods known to one having ordinaryskill in the art.

The protrusions 26 and 28 and the receiving elements 32 and 34 (e.g., atthe connection zone 118) can be fixed to the to the wall 4 or formed ofthe wall 4 by crimping, stamping, melting, screwing, gluing, welding,die cutting, laser cutting, electrical discharge machining (EDM) or acombination thereof. Cuts 162 and holes in the wall 4 can be made by diecutting, lasers or EDM.

Any part of the first prosthesis 2, or the first prosthesis 2 as a wholeafter assembly, can be coated by dip-coating or spray-coating methodsknown to one having ordinary skill in the art. One example of a methodused to coat a medical device for vascular use is provided in U.S. Pat.No. 6,358,556 by Ding et al. and hereby incorporated by reference in itsentirety. Time release coating methods known to one having ordinaryskill in the art can also be used to delay the release of an agent inthe coating. The coatings can be thrombogenic or anti-thrombogenic. Forexample, coatings on the inside of the first prosthesis 2, the sidefacing the longitudinal axis 6, can be anti-thrombogenic, and coatingson the outside of the first prosthesis, the side facing away from thelongitudinal axis 6, can be thrombogenic.

The first prosthesis 2 can be covered with a fabric, for examplepolyester (e.g., DACRON® from E. I. du Pont de Nemours and Company,Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen,silicone or combinations thereof. Methods of covering an implantabledevice with fabric are known to those having ordinary skill in the art.

Method of Use

The first prosthesis 2 can be introduced in an unexpanded state to anantechamber 202 adjacent to a targeted valve annulus 204 by methodsknown to one having ordinary skill in the art. FIG. 53 illustratespositioning and lowering, as shown by the arrows, the first prosthesis 2to the annulus 204. Because of the collapsible and expandable nature ofthe first prosthesis 2, the procedure of implanting the first prosthesis2 can be accomplished thorascopically, endoscopically and/orendoluminally. The first prosthesis 2 can be placed accurately enoughinto the annulus 204 so that the first prosthesis 2 does not blockvessel openings in chambers neighboring the annulus 204 (e.g., theopenings for the coronary vessels) and does not fall out of the annulus204 (e.g., into a chamber of the heart, a ventricle for example). Theannulus 204 can have an initial annulus diameter 206. FIG. 54illustrates positioning and seating the first prosthesis 2.

When the first prosthesis 2 is completely unexpanded, the protrusion 26and the receiving element 32 can be aligned as illustrated in FIGS. 55and 56. As shown in FIG. 55, the extension 130 can be located in thefirst setting position 98. As shown in FIG. 56, the ball 50 can belocated in the first setting position 98.

The first prosthesis 2 can be circumferentially expanded, as illustratedby the arrows in FIG. 57. The prosthesis can have an expanded annulusdiameter 208. The expanded annulus diameter 208 can be from about 5 mm(0.2 in.) to about 40 mm (1.6 in.), depends on the size of the initialannulus diameter 206, and can be influenced by other anatomy, anomalies(e.g., narrowing, stenosis) and age (e.g., pediatric sizing). Anexpansion tool 210 can be used to expand the first prosthesis 2.Examples of the expansion tool 210 include a balloon, back sides of aclamp jaws, or a flexible plug assembly as shown in FIGS. 58-61. Anotherexample of the expansion tool 210 is disclosed in U.S. Pat. No.5,984,959 to Robertson et al. which is herein incorporated by referencein its entirety.

FIG. 58 illustrates a flexible plug 212 that can be cylindrical and havea static plate 214 on a first side 216. The plug 212 can be made frompolymers, for example polyurethane or silicone. The plug 212 can have ahole 218 in the center of the plug 212. A rigid inner tube 220 can passthrough the hole 218 and be tied into a knot or pull against a washer222 on the first side 216. A squeeze plate 224 can be fixedly attachedto an end of a rigid outer tube 226. The outer tube 226 can be largerthan the inner tube 220, and the inner tube 220 can slide through theouter tube 226. A force in the direction of the plug 212 can be appliedto the outer tube 226, as shown by arrows 228. A force in the directionaway from the plug 212 can be applied to the inner tube 220, as shown byarrows 230. The plug can have a resting diameter 232 when no forces areapplied.

Once the forces shown by the arrows 228 and 230 are applied to the plug212, the plug 212 can deform away from the tubes 220 and 226, as shownby arrows 234 and illustrated in FIG. 59. Once deformed, the plug 212can have an expanded diameter 236. The resting diameter 232 and theexpanded diameter 236 can be sized appropriately to the dimensions ofthe first prosthesis 2. The deformation of the plug 212 can also createforces in the same direction as the arrows 234. When the forces shown bythe arrows 228 and 230 are removed, the plug 212 can return to the shapeshown in FIG. 58.

FIG. 60 illustrates another embodiment of the plug 212. The plug 212 canhave a recessed top surface 238 and a recessed bottom surface 240. A topperimeter 242 and a bottom perimeter 244 can be angled from the recessedsurfaces 238 and 240 to meet a wall 246 of the plug 212. The squeezeplate 224 and the static plate 214 can both be conically or partiallyconically shaped to fit the perimeters 242 and 244 of the plug 212. Asshown in FIG. 61, when the forces shown by the arrows 228 and 230 areapplied, the plug wall 246 can expand radially and maintain a flatsurface.

When the first prosthesis 2 is completely expanded, the protrusion 26and the receiving element 32 can be aligned as illustrated in FIGS. 62and 63. As shown in FIG. 62, the extension 130 can be located in thefinal stop position 110. As shown in FIG. 63, the ball 50 can be locatedin the final stop position 110. The interference fit caused by the stopangle 116 and neck width 104 of the second neck 108 can prevent theprotrusion 26 from re-entering the second setting position 106. Inaddition, when expanded the first prosthesis frictionally engages theannulus, expanding the annulus diameter. When expanded, the firstprosthesis 2 can also trap vascular plaque between the wall 4 and theperimeter of the annulus 204. The first prosthesis 2 can also bepartially expanded, forcing the protrusion 26 into the second settingposition 106.

Fixturing devices 248 can be used to fix the first prosthesis 2 throughthe fixturing device connectors 88 to the biological mass of the annulus204, as shown in FIG. 64. Examples of fixturing devices 88 are sutures,clips, staples, pins and combinations thereof.

FIGS. 65-68 illustrate one embodiment of a method of fixing the firstprosthesis 2 to the annulus 204. FIG. 65 illustrates an embodiment of afixturing device assembly 250. The fixturing device assembly 250 canhave a needle 252. The needle 252 can be curved or have a curved tip.The needle 252 can also be attached at a proximal end to a distal end ofa line 254. The proximal end of the needle 252 can also be attacheddirectly to the can 256 without the line 254 or formed as the can 256. Aproximal end of the line 254 can be attached to a can 256. The can 256can be a flexible cylindrical storage device, for example a coil. Thecan 256 can removably hold the fixturing device 248. The fixturingdevice 248 can have a fixturing element 258, for example a wire orfiber. The fixturing element 258 can have a ball 260 at a first end anda radially expandable portion 262 at a second end. The fixturing device248 can also have a pledget 264 on the fixturing element 258 between theball 260 and the expandable portion 262.

The fixturing device assembly 250 can be positioned so the needle 252 isadjacent to the fixturing device connector 88, as shown by arrows 266.The needle 252 can then be pushed through the fixturing device connector88 and the annulus 204, as shown by arrow 268 in FIG. 66. The needle 252can then be pulled away from the annulus 204, as shown by arrow 270 inFIG. 67. The can 256 can follow the path of the needle 252 through theannulus 204, as shown by arrow 272. The pledget 264 can also be largerthan the fixturing device connector 88, and the pledget 264 can providean interference fit against the fixturing device connector 88. Theneedle 252 can continue to be pulled away from the annulus 204, pullingthe can 256 out of the annulus 204, as shown by arrow 274 in FIG. 68.The interference fit of the pledget 264 against the fixturing deviceconnector 88 can provide a resistive force holding the fixturing device248 and causing the fixturing element 258 to slide out of the can 256 asthe needle 252 is pulled away from the annulus 204. The radiallyexpandable portion 262 can then radially expand, thereby causing thefirst prosthesis 2 and the annulus 204 to be fixed between the pledget264 and the radially expandable portion 262.

The inner surface of the can 256 can be designed—for example by coiling,corrugation, or other roughening—to adjust the friction between theinner surface of the can 256 and the fixturing device 248. This frictioncan influence the amount of resistive force necessary to remove thefixturing device 248 from the can 256. The resistive force can be largerthan about the force necessary to have the fixturing device 248 fall outof the can 256 before the fixturing device 248 has passed through theannulus 104. The resistive force can also be less than about the forcenecessary to deform the pledget 264 sufficient to pull the pledget 256through the fixturing device connector 88. The resistive force can be,for example, about 1.1 N (0.25 lbs.).

A second prosthesis 68 can then be positioned on the engagement element148, as shown by the arrows in FIG. 69. Once seated on the engagementelement 148, the second prosthesis 68 can then be engaged by the firstprosthesis 2, as shown in FIG. 70. Examples of second prostheses 68include a connection adapter and a heart valve crown with leaflets 276,for example, U.S. Pat. No. 6,371,983 to Lane which is hereinincorporated by reference in its entirety.

FIG. 71 illustrates another embodiment of the heart valve assembly 278with the second prosthesis 68. The first prosthesis 2 can have a taperedwall 280 to provide a longitudinal stop and to guide insertion of thesecond prosthesis 68 into the first prosthesis 2, as shown by arrows282. The tapered wall 280 can also push back the annulus 204,maintaining the expanded annulus diameter 208 when the second prosthesis68 is engaged in the first prosthesis 2. The second prosthesis 68 canhave spring lock tabs 284 to fix to the engagement element 148. Thespring lock tabs 284 can angle outwardly from the longitudinal axis 6.The first and second prostheses 2 and 68 can have first and secondprosthesis diameters 288 and 290, respectively. The first prosthesisdiameter 288 can be larger than the second prosthesis diameter 290. FIG.72 illustrates the embodiment of the heart valve assembly 278 of FIG.71, however the second prosthesis diameter 290 can be larger than thefirst prosthesis diameter 288, and the spring lock tabs 284 can angleinwardly toward the longitudinal axis 6. The first prosthesis 2 and thesecond prosthesis 68 act to maintain the expanded annular lumen diameter208.

FIG. 73 illustrates another embodiment of the heart valve assembly 278with a second prosthesis 68 that can have fixation points 286 that alignwith fixation points 286 on the first prosthesis 2 to allow insertion ofsutures, grommets, clips 292 or pins 294 through the aligned fixationpoints 286 to fix the first prosthesis 2 to the second prosthesis 68.

FIG. 74 illustrates another embodiment of the heart valve assembly 278with a multi-lobed stiffening ring 296 that can be placed near the edgeof the second prosthesis 68 as shown by arrows 298. The secondprosthesis 68 can have several flaps 300. The flaps 300 can wrap aroundthe stiffening ring 296, as shown by arrows 302. The wrapped stiffeningring 296 can increase the rigidity of the second prosthesis 68 and canengage the engagement element 148.

FIG. 75 illustrates yet another embodiment of the heart valve assembly278 with an embodiment of the first prosthesis 2 equivalent to theembodiment in FIG. 52. The second prosthesis 68 can have latch openings304 to receive the latches 188. When the second prosthesis 68 is loweredinto the first prosthesis 2, the interference beams 198 can be removed,as shown by arrows 200. The latches 188 can then contract onto the latchopenings 304.

FIG. 76 illustrates an embodiment of the heart valve assembly 278 withan embodiment of the first prosthesis 2 equivalent to the embodiment inFIGS. 11 and 12. The second prosthesis can have a rib 306 to fit withinthe groove 64. The second prosthesis 68 can also have an upper arm 308that can have a top magnet 70 and a lower arm 310 that can have a bottommagnet 72. The magnets 70 and 72 in the second prosthesis 68 can havepolarities opposite of the polarities of the corresponding magnets 70and 72 in the first prosthesis 2. FIG. 77 illustrates an embodiment ofthe heart valve assembly 278 with an embodiment of the first prosthesisequivalent to the embodiment in FIGS. 13 and 14.

FIG. 78 illustrates an embodiment of the heart valve assembly 278 withan adapter 312 connecting the second prosthesis 68 to the firstprosthesis 2. The adapter 312 can have spring lock tabs 284 to fix tothe engagement element 148, and the adapter 312 can have a stop ridge314 to position the adapter 312 against the wall 4.

The adapter 312 can also have fixation points 286 that align with otherfixation points 286 on the second prosthesis 68 to allow insertion ofsutures, grommets, clips, pins, or the fixturing devices 248, throughthe aligned fixation points 286 to fix the adapter 312 to the secondprosthesis 68. The second prosthesis 68 can also be lowered into the topof the adapter 312 as shown by arrow 316. The adapter 312 can attach tothe inside or outside of the first or second prosthesis 2 or 68depending on the dimensions and the orientation of the attachmentapparatus (e.g., unidirectional clips).

The adapter 312 can also have multiple shapes of cross-sections, asshown in FIGS. 79 and 80. As shown in FIG. 79, cross-section C-C canhave three lobes 318 and three scallops 320. One scallop 320 can bebetween each lobe 318. Cross-section C-C can be the same as thecross-section of the second prosthesis 68 where the second prosthesis 68engages the adapter 312. As shown in FIG. 80, cross-section D-D can becircular. Cross-section D-D can be the same as the cross-section of thefirst prosthesis 2 where the first prosthesis 2 engages the adapter 312.

FIG. 81 illustrates a second prosthesis 68 received by a firstprosthesis 2. The second prosthesis 68 can have three lobes 318. Thesecond prosthesis can have a scallop 320 between each two lobes 318. Thescallop gap 322 between each scallop 320 and the wall 4 can be coveredby a fabric during use of the prostheses 2 and 68.

FIG. 82 illustrates that a lever device 324, for example a clamp orscissors, can be forced, as shown by arrows, into the scallop gap 322.As illustrated in FIG. 83, once legs 326 of the lever device 324 areplaced next to two scallops 320, the lever device 324 can be squeezed,as shown by arrows, thereby crushing the second prosthesis 68 andseparating it from the first prosthesis 2. As illustrated in FIG. 84,the second prosthesis 68 can be removed from the first prosthesis 2, asshown by arrows, once the second prosthesis 68 is separated from thefirst prosthesis 2. Once the second prosthesis 68 is removed, a newsecond prosthesis 68 can be added as described above. Leaflet failurecan be fixed easily and inexpensively by implanting a new secondprosthesis 68. Circumferential expansion of the first prosthesis 2 andreplacement of the second prosthesis 68 to account for pediatricexpansion of the valve can also be performed easily and inexpensively.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,without departing from the spirit and scope of the invention. Elementsshown with any embodiment are exemplary for the specific embodiment andcan be used on other embodiments within this disclosure.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure.

1. A method for implanting a heart valve in a tissue annulus within apatient's heart, comprising: positioning a first annular prosthesiswithin the tissue annulus in an unexpanded state, wherein the firstannular prosthesis comprises a circular circumference; expanding thefirst prosthesis to an expanded state within the tissue annulus tocontact surrounding tissue; fixing the first prosthesis to tissuesurrounding the tissue annulus; introducing a second valve prosthesisinto the tissue annulus after fixing the first prosthesis; introducing aconnection adapter into the tissue annulus, the connection adapterincluding a multi-lobed circumference; and securing the secondprosthesis relative to the first prosthesis within the tissue annulususing the connection adapter.
 2. The method of claim 1, wherein thefirst prosthesis is expanded within the tissue annulus by releasing thefirst prosthesis such that the first prosthesis resiliently expandswithin the tissue annulus.
 3. The method of claim 1, wherein the firstprosthesis is expanded within the tissue annulus using an expansiontool.
 4. The method of claim 3, wherein the expansion tool comprises oneof a balloon, a clamp, and a flexible plug assembly.
 5. The method ofclaim 1, wherein the first prosthesis comprises an annular ring that isfolded in the unexpanded state and wherein the annular ring issubstantially circular in the expanded state.
 6. The method of claim 1,wherein the first prosthesis is fixed to tissue by inserting a pluralityof fixturing devices through the first prosthesis into tissuesurrounding the tissue annulus.
 7. The method of claim 6, wherein thefirst prosthesis comprises fixturing device connectors, and wherein thefixturing devices are pushed through the fixturing device connectorsinto tissue surrounding the tissue annulus.
 8. The method of claim 6,wherein the fixturing device comprise at least one of sutures, clips,staples, and pins.
 9. The method of claim 1, wherein securing the secondprosthesis comprises snap-fitting the second prosthesis to the firstprosthesis.
 10. The method of claim 1, wherein securing the secondprosthesis comprises engaging a plurality of engagement elements on thefirst and second prostheses.
 11. The method of claim 10, wherein theengagement elements allow the second prosthesis to be secured relativeto the first prosthesis only in a predetermined angular orientationabout a central axis of the first and second prostheses.
 12. The methodof claim 1, wherein securing the second prosthesis comprises: angularlyorienting the second prosthesis about a central longitudinal axis of thefirst and second prostheses relative to the first prosthesis to alignthe second prosthesis with the first prosthesis in a predeterminedangular orientation; and directing the second prosthesis into engagementwith the first prosthesis to secure the second prosthesis in thepredetermined angular orientation.
 13. The method of claim 1, whereinthe second prosthesis comprises a frame having a multiple lobed shapeincluding a latitudinal cross-section in a plane perpendicular to acentral longitudinal axis of the second prosthesis defining multiplelobes separated by scallops, and wherein the first prosthesis comprisesan annular ring having a substantially circular circumference in theexpanded state.
 14. The method of claim 13, wherein the secondprosthesis is introduced into the tissue annulus with the frame in themultiple lobed shape.
 15. The method of claim 14, further comprisingangularly orienting the second prosthesis about the central longitudinalaxis before securing the second prosthesis.
 16. A method for implantinga heart valve in a tissue annulus within a patient's heart, comprising:positioning a first annular prosthesis within the tissue annulus in anunexpanded state, the first prosthesis comprising an annular ring thatis folded in the unexpanded state; expanding the first prosthesis to anexpanded state within the tissue annulus wherein the annular ringcomprises a substantially circular diameter contacting surroundingtissue; fixing the first prosthesis to the tissue annulus by introducinga plurality of fixturing devices through the first prosthesis intotissue surrounding the tissue annulus; introducing a second valveprosthesis into the tissue annulus after fixing the first prosthesis,the second prosthesis comprising a frame having a plurality of leafletsattached to the frame; introducing a connection adapter into the tissueannulus, the connection adapter having a multi-lobed circumference; andsecuring the second prosthesis relative to the first prosthesis withinthe tissue annulus using the connection adapter.
 17. The method of claim16, wherein the first prosthesis is expanded within the tissue annulusby releasing the first prosthesis such that the annular ring resilientlyexpands within the tissue annulus.
 18. The method of claim 16, whereinthe plurality of fixturing devices comprise at least one of sutures,clips, staples, and pins.
 19. The method of claim 16, wherein securingthe second prosthesis comprises snap-fitting the second prosthesis tothe first prosthesis.
 20. The method of claim 16, wherein securing thesecond prosthesis comprises engaging a plurality of engagement elementson the first and second prostheses.